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Objective: To investigate the feasibility and acceptability of SleepWell24 , a multicomponent, evidence-based smartphone application, to improve positive airway pressure therapy (PAP) adherence, among patients with obstructive sleep apnea (OSA) naive to PAP., Methods: In a single-blind randomized controlled trial, SleepWell24 , with a companion activity monitor was compared to usual care plus the activity monitor and its associated app. SleepWell24 provides objective feedback on PAP usage and sleep/physical activity patterns, and chronic disease management. Patients were recruited from two sleep medicine centers and followed over the first 60 days of PAP. Feasibility and acceptability were measured by recruitment/retention rates, app usage, differences in post-trial Treatment Evaluation Questionnaire (TEQ) scores, and patient interviews. Exploratory, intent-to-treat logistic and linear mixed models estimated PAP adherence and clinical outcomes., Results: Of 103 eligible participants, 87 were enrolled ( SleepWell24 n  = 40, control n  = 47; mean 57.6y [SD = 12.3], 44.8% female). Retention was ≥95% across arms. There were no significant differences in TEQ scores. SleepWell24 participants engaged with the app on 62.9% of trial days. PAP use was high across both arms ( SleepWell24 vs. Control: mean hours 5.98 vs. 5.86). There were no differences in PAP adherence or clinical outcomes., Conclusions: SleepWell24 was feasible and acceptable among PAP-naive patients with OSA., Clinical Trial Registration: NCT03156283https://www.clinicaltrials.gov/study/NCT03156283.

Demand for kidney grafts outpaces supply, limiting kidney transplantation as a treatment for kidney failure. Xenotransplantation has the potential to make kidney transplantation available to many more patients with kidney failure, but the ability of xenografts to support human physiologic homeostasis has not been established. A brain-dead adult decedent underwent bilateral native nephrectomies followed by 10 gene-edited (four gene knockouts, six human transgenes) pig-to-human xenotransplantation. Physiologic parameters and laboratory values were measured for seven days in a critical care setting. Data collection aimed to assess homeostasis by measuring components of the renin-angiotensin-aldosterone system, parathyroid hormone signaling, glomerular filtration rate, and markers of salt and water balance. Mean arterial blood pressure was maintained above 60 mmHg throughout. Pig kidneys secreted renin (post-operative day three to seven mean and standard deviation: 47.3 ± 9 pg/mL). Aldosterone and angiotensin II levels were present (post-operative day three to seven, 57.0 ± 8 pg/mL and 5.4 ± 4.3 pg/mL, respectively) despite plasma renin activity under 0.6 ng/mL/hr. Parathyroid hormone levels followed ionized calcium. Urine output down trended from 37 L to 6 L per day with 4.5 L of electrolyte free water loss on post-operative day six. Aquaporin 2 channels were detected in the apical surface of principal cells, supporting pig kidney response to human vasopressin. Serum creatinine down trended to 0.9 mg/dL by day seven. Glomerular filtration rate ranged 90-240 mL/min by creatinine clearance and single-dose inulin clearance. Thus, in a human decedent model, xenotransplantation of 10 gene-edited pig kidneys provided physiologic balance for seven days. Hence, our in-human study paves the way for future clinical study of pig-to-human kidney xenotransplantation in living persons., (Copyright © 2024 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.)

Introduction: Cultural factors are constructs that capture important life experiences of Latinx/Hispanic individuals, families, and communities. Despite their importance for Latinx communities, Latinx cultural factors have yet to be fully incorporated into the literature of many social, behavioral science, and health service fields, including implementation science. This significant gap in the literature has limited in-depth assessments and a more complete understanding of the cultural life experiences of diverse Latinx community residents. This gap has also stifled the cultural adaptation, dissemination, and implementation of evidence based interventions (EBIs). Addressing this gap can inform the design, dissemination, adoption, implementation, and sustainability of EBIs developed to serve Latinx and other ethnocultural groups., Methods: Based on a prior Framework Synthesis systematic review of Latinx stress-coping research for the years 2000-2020, our research team conducted a thematic analysis to identify salient Latinx cultural factors in this research field. This thematic analysis examined the Discussion sections of 60 quality empirical journal articles previously included into this prior Framework Synthesis literature review. In Part 1, our team conducted an exploratory analysis of potential Latinx cultural factors mentioned in these Discussion sections. In Part 2 we conducted a confirmatory analysis using NVivo 12 for a rigorous confirmatory thematic analysis., Results: This procedure identified 13 salient Latinx cultural factors mentioned frequently in quality empirical research within the field of Latinx stress-coping research during the years 2000-2020., Discussion: We defined and examined how these salient Latinx cultural factors can be incorporated into intervention implementation strategies and can be expanded to facilitate EBI implementation within diverse Latinx community settings., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Castro, Berkel and Epstein.)

Objectives: To describe changes in sleep patterns during the coronavirus disease 2019 (COVID-19) pandemic, develop profiles according to these patterns, and assess sociodemographic, economic, COVID-19 related, and sleep and mental health factors associated with these profiles., Design, Setting, and Participants: A 25-minute online survey was distributed worldwide through social media from 5/21/2020 to 7/1/2020., Measurements: Participants reported sociodemographic/economic information, the impact of the pandemic on major life domains, insomnia and depressive symptoms, and changes in sleep midpoint, time-in-bed, total sleep time (TST), sleep efficiency (SE), and nightmare and nap frequency from prior to during the pandemic. Sleep pattern changes were subjected to latent profile analysis. The identified profiles were compared to one another on all aforementioned factors using probit regression analyses., Results: The sample of 991 participants (ages: 18-80 years; 72.5% women; 60.3% residing outside of the United States) reported significantly delayed sleep midpoint, reductions in TST and SE, and increases in nightmares and naps. Over half reported significant insomnia symptoms, and almost two-thirds reported significant depressive symptoms. Latent profile analysis revealed 4 sleep pattern change profiles that were significantly differentiated by pre-pandemic sleep patterns, gender, and various COVID-19-related impacts on daily living such as severity of change in routines, and family stress and discord., Conclusions: In an international online sample, poor sleep and depressive symptoms were widespread, and negative shifts in sleep patterns from pre-pandemic patterns were common. Differences in sleep pattern response to the COVID-19 crisis suggest potential and early targets for behavioral sleep health interventions., Competing Interests: Declaration of conflict of interest The authors do not have any conflicts of interest to disclose., (Copyright © 2021 National Sleep Foundation. Published by Elsevier Inc. All rights reserved.)

Background : Patients receiving Cognitive Processing Therapy (CPT), an evidence based therapy for posttraumatic stress disorder (PTSD), report improved sleep quality. However, the majority of studies have examined residual sleep disturbance via self-report surveys or separate items on PTSD measures. This study examined whether CPT delivered to veterans in a VA setting improved sleep indices using state-of-the-art objective and subjective insomnia measures. Participants : Participants were war veterans with a current PTSD diagnosis scheduled to begin outpatient individual or group CPT at two Veteran's Affairs (VA) locations (n = 37). Methods : Sleep symptom severity was assessed using the recommended research consensus insomnia assessment, the consensus daily sleep diary and actigraphy. PTSD symptomatology pre- and post-treatment were assessed using the Clinician Administered PTSD Scale. Results : A small to moderate benefit was observed for the change in PTSD symptoms across treatment (ES RMC  = .43). Effect sizes for changes on daily sleep diary and actigraphy variables after CPT were found to be negligible (Range ES RMC  = - .16 to .17). Sleep indices remained at symptomatic clinical levels post-treatment. Discussion : These findings support previous research demonstrating a need for independent clinical attention to address insomnia either before, during, or after PTSD treatment.

Background: Positive airway pressure (PAP) therapy is the gold standard treatment for obstructive sleep apnea (OSA), a chronic disorder that affects 6-13% of the adult population. However, adherence to PAP therapy is challenging, and current approaches to improve adherence have limited efficacy and scalability., Methods/design: To promote PAP adherence, we developed SleepWell24, a multicomponent, evidence-based smartphone application that delivers objective biofeedback concerning PAP use and sleep/physical activity patterns via cloud-based PAP machine and wearable sensor data, and behavior change strategies and troubleshooting of PAP therapy interface use. This randomized controlled trial will evaluate the feasibility, acceptability, and initial efficacy of SleepWell24 compared to a usual care control condition during the first 60 days of PAP therapy among patients newly diagnosed with OSA., Discussion: SleepWell24 is an innovative, multi-component behavior change intervention, designed as a self-management approach to addressing the psychosocial determinants of adherence to PAP therapy among new users. The results will guide lengthier future trials that assess numerous patient-centered and clinical outcomes., (Copyright © 2019 Elsevier Inc. All rights reserved.)

This study investigated the feasibility and preliminary effectiveness of a pilot program designed to address subjective memory complaints among Veterans. The program, Brain Boosters, consisted of 10 once-weekly group sessions, during which psychoeducation and cognitive enhancement strategies were used to target memory concerns and related processes, specifically attentional difficulties. Given that memory complaints often are associated with psychiatric comorbidities, sessions also incorporated strategies for reducing symptoms of depression, posttraumatic stress, and insomnia. Controlling for age, we examined pre- to posttreatment change in symptom ratings for 96 Veterans (aged 22 to 87 years) who participated in the Brain Boosters program. The effect of Brain Boosters on memory complaints interacted with age: younger (but not older) Veterans reported reductions in memory impairment from pre- to posttreatment. Additionally, irrespective of age, from pre- to posttreatment Veterans reported fewer attentional difficulties and fewer depression symptoms. Ratings of posttraumatic stress and insomnia symptoms did not change, although insomnia was negatively associated with age. Linear regression controlling for age revealed that reductions in attention problems predicted reductions in perceived memory impairment. Findings from this exploratory, uncontrolled pilot study suggest that a psychoeducational cognitive enhancement group is feasible to conduct in a heterogeneous Veteran population, and may be associated with improvements in perceived memory functioning for younger Veterans, and in attention and depression symptoms for Veterans across age groups. (PsycINFO Database Record (c) 2020 APA, all rights reserved).

Within the behavioral field, a plethora of conceptual frameworks and tools have been developed to improve transition from efficacy to effectiveness trials; however, they are limited in their ability to support new, iterative intervention design decision-making methodologies beyond traditional randomized controlled trial design. Emerging theories suggest that researchers should employ engineering based user-centered design (UCD) methods to support more iterative intervention design decision-making in the behavioral field. We present, an adaptation of a UCD tool used in the engineering field-the Quality Function Deployment "House of Quality" correlation matrix, to support iterative intervention design decision-making and documentation for multicomponent behavioral interventions and factorial trial designs. We provide a detailed description of the adapted tool-"House of Quality for Behavioral Science", and a step-by-step use-case scenario to demonstrate the early identification of intervention flaws and prioritization of requirements. Four intervention design flaws were identified via the tool application. Completion of the relationship correlation matrix increased requirement ranking variance for the researcher (σ2 = 0.47 to 7.19) and participant (σ2 = 0.56 to 3.89) perspective. Requirement prioritization (ranking) was facilitated by factoring in the strength of the correlation between each perspective and corresponding importance. A correlational matrix tool such as the "House of Quality for Behavioral Science" may provide a structured, UCD approach that balances researcher and participant needs and identifies design flaws for pragmatic behavioral intervention design. This tool may support iterative design decision-making for multicomponent and factorial trial designs., (© Society of Behavioral Medicine 2018. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Single- and multiple-component therapies are recommended in professional guidelines for managing chronic insomnia. Systematic reviews point to insufficient evidence of the comparative effectiveness of these therapies, which is required for treatment decision making., Purpose: To compare the effectiveness of three single-component and one multiple-component therapies on short-term sleep outcomes., Methods: The data were obtained from 517 persons with chronic insomnia, enrolled in a partially randomized preference trial. They were allocated to the single-component therapies: sleep education and hygiene (SEH), stimulus control therapy (SCT), and sleep restriction therapy (SRT), or the multiple-component therapy (MCT). The outcomes, perceived insomnia severity and sleep parameters, were assessed with established measures at pre and posttest. Repeated measure analysis of variance was used to compare the outcomes across therapy groups over time. The clinical relevance of the therapies' effects was evaluated by examining the effect size and remission rate., Results: The four therapies differed in their effectiveness in reducing perceived insomnia severity and improving sleep outcomes. SEH was least effective. SCT, SRT, and MCT were moderately effective. SCT and SRT demonstrated slightly higher remission rates than MCT for perceived insomnia severity and some sleep parameters., Linking Evidence to Action: SCT and SRT are viable single-component therapies that produce clinical benefits. Single-component insomnia treatment may be more convenient to implement in the primary care setting due to the reduced number of treatment recommendations compared to MCT., (© 2019 Sigma Theta Tau International.)

Treatment satisfaction, which refers to the positive appraisal of process and outcome attributes of a treatment, is a prominent indicator of quality care. Although it is known that participant, treatment, and outcome factors influence treatment satisfaction, it remains unclear which factors contribute to satisfaction with each process and outcome attribute. In this study, we examined the extent to which participant (age, gender, education, race, employment), treatment (type of therapy, method of assignment to therapy), and outcome (self-reported improvement in outcome) factors contribute to satisfaction with the process and outcome attributes of therapies for insomnia. This study consists of a secondary analysis of data obtained from a partially randomized preference trial in which persons with chronic insomnia (N = 517) were assigned to treatment randomly or by preference. Four types of behavioral therapies were included: sleep hygiene, stimulus control therapy, sleep restriction therapy, and multi-component therapy. Self-reported improvement in insomnia and satisfaction were assessed with validated measures at post-test. Multiple regression analysis was used to examine which factors influenced satisfaction with each treatment attribute. The findings showed that treatment and outcome, more so than participant, factors influenced satisfaction with the process and outcome attributes of the behavioral therapies for insomnia. Future research on satisfaction should explore the contribution of treatment (type and preference-matching) and outcome factors on satisfaction to build a better understanding of treatment attributes viewed favorably. Such understanding has the potential to inform modifying or tailoring treatments to improve their acceptance to participants and optimize their effectiveness., (© 2018 Wiley Periodicals, Inc.)

Patient-centered care involves the provision of treatments that are responsive to patients' preferences. This study aimed to examine the psychometric properties of the Treatment Perception and Preferences measure. Participants ( n = 128) completed the measure relative to pharmacological, educational, and behavioral treatments for the management of insomnia. For each treatment, the measure presents a description of its goal, activities, mode and dose of delivery, and nine items to rate its perceived acceptability. All items measuring perception of treatment were internally consistent (α > .85) and loaded on one factor, except the item assessing severity of side effects. Differences in the measure's scores between groups of participants provided evidence of validity: participants with a preference for a particular treatment rated it more favorably than alternative treatments. The measure provides a systematic and efficient method for eliciting well-informed treatment preferences. Its use in practice should be investigated.

Objective: This study tested concordance between consumers' and providers' reports of personal goal setting and its relationship to self-reported goal attainment., Methods: Data are from the Israeli Psychiatric Rehabilitation Patient Reported Outcome Measurement project. Consumers (N=2,885) and the providers who were most knowledgeable about their care indicated two domains from a list of ten in which consumers had set goals during the previous year. Consumers reported on goal attainment in each domain., Results: A total of 2,345 consumers (82%) reported a personal goal. Overall, consumer-provider concordance reached 54%. Concordance was greatest in the employment (76%), housing (71%), and intimate relationship (52%) domains and lowest in family relationships (23%) and finances (15%). For most domains, concordance was less than 50%. On average, 75% of consumers reported having achieved their goals. Consumer-provider concordance was associated with goal attainment (p<.001)., Conclusions: These findings emphasize the importance of agreed-upon goals and call for conceptualizing goal setting as an interpersonal process central to recovery.

Treatment satisfaction is recognized as an essential aspect in the evaluation of an intervention's effectiveness, but there is no measure that provides for its comprehensive assessment with regard to behavioral interventions. Informed by a conceptualization generated from a literature review, we developed a measure that covers several domains of satisfaction with behavioral interventions. In this paper, we briefly review its conceptualization and describe the Multi-Dimensional Treatment Satisfaction Measure (MDTSM) subscales. Satisfaction refers to the appraisal of the treatment's process and outcome attributes. The MDTSM has 11 subscales assessing treatment process and outcome attributes: treatment components' suitability and utility, attitude toward treatment, desire for continued treatment use, therapist competence and interpersonal style, format and dose, perceived benefits of the health problem and everyday functioning, discomfort, and attribution of outcomes to treatment. The MDTSM was completed by persons (N = 213) in the intervention group in a large trial of a multi-component behavioral intervention for insomnia within 1 week following treatment completion. The MDTSM's subscales demonstrated internal consistency reliability (α: .65 - .93) and validity (correlated with self-reported adherence and perceived insomnia severity at post-test). The MDTSM subscales can be used to assess satisfaction with behavioral interventions and point to aspects of treatments that are viewed favorably or unfavorably., (© 2017 Wiley Periodicals, Inc.)

Rationale, Aims and Objectives: Randomization to treatment is viewed unfavourably by many trial participants. There is limited research that investigated factors contributing to acceptance of randomization. This study explored the influence of participants' socio-demographic and clinical characteristics, and their perceived acceptability of the treatments on their acceptance of randomization (i.e. willingness to be randomized) in a clinical trial., Methods: Persons with insomnia (n = 383) were asked about their acceptance of randomization before and after they rated the acceptability of behavioural therapies for managing insomnia (sleep education and hygiene booklet, stimulus control therapy and sleep restriction therapy). Socio-demographic and clinical characteristics, and treatment acceptability, were measured with established instruments. Logistic regression was applied to explore the association between participants' characteristics and treatment acceptability, and reported acceptance of randomization., Results: Prior to rating treatments' acceptability, 54.6% of participants were willing to be randomized; socio-demographic (age and ethnicity) and clinical (severity of insomnia's impact, state anxiety, depression, vitality and mental and social functions) contributed to acceptance of randomization. After rating the treatments' acceptability, 87.8% of participants were unwilling to be randomized; age, severity of insomnia's impact and acceptability of behavioural therapy were significantly associated with acceptance of randomization., Conclusions: The study findings indicated that participants are likely to express unwillingness to be randomized once they receive treatment information and rate the acceptability of treatments. The reported non-acceptance may influence participants' behaviour (e.g. withdrawal, non-adherence) during the trial, suggesting the need to explore alternative designs for intervention evaluation., (© 2015 John Wiley & Sons, Ltd.)

Lifestyle behaviors across the 24-h spectrum (i.e., sleep, sedentary, and active behaviors) drive metabolic risk. We describe the development and process evaluation of BeWell24, a multicomponent smartphone application (or "app") that targets behavior change in these interdependent behaviors. A community-embedded iterative design framework was used to develop the app. An 8-week multiphase optimization strategy design study was used to test the initial efficacy of the sleep, sedentary, and exercise components of the app. Process evaluation outcomes included objectively measured app usage statistics (e.g., minutes of usage, self-monitoring patterns), user experience interviews, and satisfaction ratings. Participants (N = 26) logged approximately 60 % of their sleep, sedentary, and exercise behaviors, which took 3-4 min/day to complete. Usage of the sleep and sedentary components peaked at week 2 and remained high throughout the intervention. Exercise component use was low. User experiences were mixed, and overall satisfaction was modest.

Background: Although satisfaction is recognized as an essential aspect in the evaluation of interventions' effectiveness, there is lack of clarity on its conceptualization and operationalization. In this article, we present conceptual and operational definitions that specify the domains and attributes of satisfaction with nonpharmacological interventions., Methods: An integrative review of conceptual and empirical literature was conducted to generate the conceptual and operational definitions of satisfaction with interventions. Fifty-six publications were included in the review. The definitions of satisfaction and the content of instruments measuring satisfaction were reviewed, compared, and contrasted to identify the domains and attributes of the concept., Results: Satisfaction is defined as the appraisal of the interventions' process and outcome. It is operationalized in 4 domains of process: (a) suitability and utility of the intervention's components, (b) attitude toward and desire to continue with the intervention, (c) competence and interpersonal style of interventionist, and (d) implementation (format and dose) of the intervention. The outcome domain includes improvement in the health problem and in everyday functions, discomfort, and attribution of the outcomes to the intervention., Conclusions: The conceptual and operational definitions can guide the development of instruments to assess satisfaction with nonpharmacological interventions, which can point to aspects of interventions that are viewed favorably or unfavorably.

The overall purpose of this methodological study was to investigate the strengths and limitations of the randomized clinical trial design in examining the influence of treatment preferences on outcomes. The study was a secondary analysis of data obtained in two randomized clinical trials that evaluated behavioral therapies for insomnia. In both trials, the same design and methods were used to assess participants' treatment preferences and outcomes, however, the treatments differed. The results illustrated the challenges encountered in using the randomized clinical trial design. The challenges were related to the unbalanced distribution of participants with preferences for the study treatments, non-comparability of the subgroups with treatments matched or mismatched to their preferences, differential attrition, which compromised the sample size and composition of the subgroups and limited the use of the planned statistical analyses. Whether these challenges occur in trials of other types of treatments and target populations should be explored in future research. Some strategies were proposed and should be evaluated for their utility in addressing these challenges.

Background: Prostate cancer is a common type of cancer worldwide and in the United States. However, little information has been reported on the symptoms of men over time who receive radiation therapy., Objective: The objectives of this study were to identify subgroups of men at pre- and post-radiation therapy on general and treatment-related symptoms and to determine transitions in subgroup membership over time., Methods: Men (n = 84) receiving radiation therapy completed questionnaires on fatigue, insomnia, pain, depression, anxiety, and sexual, urinary, and bowel problems at pretreatment and posttreatment. Latent class analysis identified subgroups. One-way analyses of variance determined subgroups differed on symptoms, participant characteristics, and quality of life. Latent transition analysis examined subgroup transitions over time., Results: At pretreatment, 4 subgroups were identified: resilient group, with little to no symptom reporting; adjusted group, with moderately high treatment-related symptoms, low insomnia, depression, and anxiety; distressed group, consistently high on most symptoms; and emerging group, with moderately high fatigue, depression, and anxiety with few treatment-related symptoms. At posttreatment, similar results were seen in groups to those at pretreatment: resilient, adjusted. and distressed groups with an impacted group having high pain, insomnia, depression, and urinary and bowel symptoms. Quality of life and participant characteristics further distinguished groups at pretreatment and posttreatment. Income level predicted a transition in group membership., Conclusions: Men can be classified into distinctly different subgroups over time., Implications for Practice: Assessment and intervention with men in subgroups such as distressed and emerging before and during treatment may lessen potential for remaining distressed or moving into impacted group where symptom severity is high at posttreatment. Interventions to reduce multiple symptoms are vitally needed.

Periodicities (repeating patterns) are observed in many human behaviors. Their strength may capture untapped patterns that incorporate sleep, sedentary, and active behaviors into a single metric indicative of better health. We present a framework to detect periodicities from longitudinal wrist-worn accelerometry data. GENEActiv accelerometer data were collected from 20 participants (17 men, 3 women, aged 35-65) continuously for 64.4 ± 26.2 (range: 13.9 to 102.0) consecutive days. Cardiometabolic risk biomarkers and health-related quality of life metrics were assessed at baseline. Periodograms were constructed to determine patterns emergent from the accelerometer data. Periodicity strength was calculated using circular autocorrelations for time-lagged windows. The most notable periodicity was at 24 h, indicating a circadian rest-activity cycle; however, its strength varied significantly across participants. Periodicity strength was most consistently associated with LDL-cholesterol (r's = 0.40-0.79, P's < 0.05) and triglycerides (r's = 0.68-0.86, P's < 0.05) but also associated with hs-CRP and health-related quality of life, even after adjusting for demographics and self-rated physical activity and insomnia symptoms. Our framework demonstrates a new method for characterizing behavior patterns longitudinally which captures relationships between 24 h accelerometry data and health outcomes.

Background: Empirical evidence pertaining to the influence of treatment preferences on attrition, adherence and outcomes in intervention evaluation trials is inconsistent. The inconsistency can be explained by the method used for allocating treatment and measuring preferences. The current methodological study is designed to address these factors by implementing the two-stage partially randomized or preference trial design, and administering a validated measure to assess participants' preferences for the treatments under evaluation. It aims to compare attrition, adherence and outcomes for participants allocated randomly or by preference to treatment. The study is in its final stages of data collection; its protocol is presented in this paper., Methods/design: A partially randomized clinical or preference trial is used. Eligible participants are randomized to two trial arms. First is the random arm involving random assignment to treatments, and second is the preference arm involving allocation to the chosen treatment. Participants with chronic insomnia are targeted. Two behavioral treatments are offered, stimulus control therapy and sleep restriction therapy, in the same format (small group) and dose (two sessions given over a 4-week period). A participant log is used to collect data on attrition. Adherence is evaluated in terms of exposure and enactment of treatment. Sleep-related outcomes (sleep parameters and perceived insomnia severity) are measured at pretest, posttest, 6 and 12 month follow-up. Treatment preferences, adherence and outcomes are assessed with reliable and valid measures., Discussion: The advantages and limitations of the preference trial design are highlighted. The challenges in implementing the trial are discussed relative to the distribution of participants in the groups defined by treatment received and method of treatment allocation., Trial Registration: ClinicalTrials.gov Registry NCT02513017.

The purpose of this methodological study was to examine the contribution of treatment allocation method (random vs. preference) on the immediate, intermediate, and ultimate outcomes of a behavioural intervention (MCI) for insomnia. Participants were allocated to the MCI randomly or by preference. Outcomes were assessed before, during, and after completion of the MCI using validated self-report measures. Analysis of covariance was used to compare the post-test outcomes for the 2 groups, controlling for baseline differences. Compared to those randomized, participants in the preference group showed improvement in most immediate outcomes (sleep onset latency, wake after sleep onset, sleep efficiency), both intermediate outcomes (insomnia severity and daytime fatigue), and one ultimate outcome (resolution of insomnia). Using a systematic method for eliciting participants' preferences and involving participants in treatment selection had a beneficial impact on immediate and intermediate outcomes. Additional research should validate the mechanism through which treatment preferences contribute to outcomes., (Copyright© by Ingram School of Nursing, McGill University.)

Adherence to treatment is critical in determining the effects of behavioural therapy and may be affected by participants' preference for treatment. The purpose of this study was to determine the extent to which method of allocation to treatment (random vs. preference-based) influences adherence (exposure and enactment) to behavioural therapy. Participants received behavioural therapy for the management of insomnia randomly or by preference. Exposure was assessed as attendance at the treatment sessions, enactment as self-reported application of treatment recommendations. Participants (N = 262) attended a mean of 5.6 treatment sessions, applied the treatment recommendations frequently, and reported high levels of overall compliance. There was no difference between the random and preference groups in terms of exposure to and enactment of treatment. Randomization to the preferred treatment, dissatisfaction with the allocated treatment, and self-report bias could play a role in the findings and should be explored in future research., (Copyright© by Ingram School of Nursing, McGill University.)

Preferences for treatment contribute to attrition. Providing participants with their preferred treatment, as done in a partially randomized clinical or preference trial (PRCT), is a means to mitigate the influence of treatment preferences on attrition. This study examined attrition in an RCT and a PRCT. Persons with insomnia were randomly assigned (n = 150) or allocated (n = 198) to the preferred treatment. The number of dropouts at different time points in the study arms was documented and the influence of participant characteristics and treatment-related factors on attrition was examined. The overall attrition rate was higher in the RCT arm (46%) than in the PRCT arm (33%). In both arms, differences in sociodemographic and clinical characteristics were found between dropouts and completers. The type of treatment significantly predicted attrition (all p ≤ .05). The results provide some evidence of a lower attrition rate in the PRCT arm, supporting the benefit of accounting for preferences as a method of treatment allocation., (Copyright© by Ingram School of Nursing, McGill University.)

Insomnia and depression are prevalent and co-occurring conditions that are associated with significant impairment of life. Previous research indicates that cognitive-behavioral interventions for insomnia (CBT-I) can improve both insomnia and depressive symptoms. The aim of the authors in this study was to determine whether a multi-component behavioral intervention (MCI) improved both insomnia and depressive symptoms in persons presenting with insomnia and high levels of depression. The sample consisted of 321 individuals with insomnia who participated in a trial of insomnia treatments; 106 participants had high levels of depression (score ≥ 16 on CES-D) at baseline. Participants either received the MCI or a control treatment (sleep education and hygiene booklet). At post-test, participants with high and low levels of depressive symptoms showed significant improvement in insomnia symptoms. Those with high depression also had significant reductions in depressive symptoms. It can be concluded that for individuals with depression and insomnia, CBT-I is a viable intervention for managing depressive symptoms, which complements other approaches for treating depression.

Sleep restriction therapy is routinely used within cognitive behavioral therapy to treat chronic insomnia. However, the efficacy for sleep restriction therapy as a standalone intervention has yet to be comprehensively reviewed. This review evaluates the evidence for the use of sleep restriction therapy in the treatment of chronic insomnia. The literature was searched using web-based databases, finding 1344 studies. Twenty-one were accessed in full (1323 were deemed irrelevant to this review). Nine were considered relevant and evaluated in relation to study design using a standardized study checklist and levels of evidence. Four trials met adequate methodological strength to examine the efficacy of therapy for chronic insomnia. Weighted effect sizes for self-reported sleep diary measures of sleep onset latency, wake time after sleep onset, and sleep efficiency were moderate-to-large after therapy. Total sleep time indicated a small improvement. Standalone sleep restriction therapy is efficacious for the treatment of chronic insomnia for sleep diary continuity variables. Studies are insufficient to evaluate the full impact on objective sleep variables. Measures of daytime functioning in response to therapy are lacking. Variability in the sleep restriction therapy implementation methods precludes any strong conclusions regarding the true impact of therapy. A future research agenda is outlined., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Purpose/objectives: To examine the trajectory of changes in body composition and metabolic profile in men who receive androgen-deprivation therapy (ADT) for prostate cancer., Design: Prospective longitudinal design with repeated measures., Setting: Urban medical center in the southwestern United States., Sample: 55 men starting radiation therapy for prostate cancer., Methods: Changes in the parameters of metabolic syndrome were estimated with ADT (n=31) and non-ADT (n=24) groups by repeated-measures analysis of variance implemented by general linear mixed-effects models. Models included interactions between groups and follow-up time to test differences between the groups., Main Research Variables: Body composition and metabolic variables., Findings: The ADT group demonstrated a transient increase in waist circumference at the nine-month time point and significant changes in measures of insulin resistance were noted at the three month point. Values for diastolic and systolic blood pressure, plasma glucose, high-density lipoprotein, and triglycerides were not altered for either group. Differences in metabolic variables or measures of body composition did not differ significantly between the groups., Conclusions: The findings demonstrate the development of insulin resistance in men receiving ADT as early as three months after starting ADT., Implications for Nursing: Addressing survivorship concerns can lead to the development of nursing interventions designed to reduce adverse effects associated with ADT.

Purpose/objectives: To investigate acceptability of and preferences for physical activity participation in men receiving androgen-deprivation therapy (ADT) for prostate cancer, to identify influencing clinical and demographic factors, and to determine the percentage meeting national exercise guidelines., Design: Cross-sectional, descriptive., Setting: Ambulatory care clinic of a large medical center., Sample: 135 men receiving ADT., Methods: A structured interview with a systematic procedure was used to elicit preferences for physical activity., Main Research Variables: Exercise preferences and acceptability; evidence-based exercise intervention., Findings: Participants expressed high levels of acceptability of and willingness to participate in aerobic (64% and 79%) and muscle-strengthening (79% and 81%) programs. Preferences were expressed for muscle-strengthening activities performed at home, either alone or in the company of a family member. Flexible, spontaneous, and self-paced programs were preferred. Significant associations were identified for distance, age, obesity, duration of ADT, and meeting American College of Sports Medicine (ACSM) and American Heart Association (AHA) guidelines. Nineteen percent of the study population met the guidelines for weekly physical activity., Conclusions: High levels of expressed acceptance of and willingness to participate in physical activity programs as well as the small number of participants meeting ACSM and AHA guidelines suggest feasibility of and support the need for the development of exercise programs in this population., Implications for Nursing: Incorporating patient preferences and evidence-based practice is integral to providing high-quality patient-centered care and is the foundation for appropriate intervention programs. Insight from this study will facilitate the design of programs that better reflect actual preferences of prostate cancer survivors., Knowledge Translation: ADT-induced changes in body composition are believed to contribute to a reduction in insulin sensitivity and dyslipidemia that contribute to increased cardiovascular risk profile. Exercise has the potential to mitigate the harmful effects of ADT.

Purpose: The study determined the feasibility of implementing a brief, preference-based non-medication insomnia treatment for Iraq/Afghanistan war Veterans who experienced blast and/or other injuries resulting in an altered level of consciousness., Methods: The study used a one-group pre-post design with a 3-month follow-up assessment. Forty-one veterans (two females, mean age 30.32 ± 7.73 years) with a mean insomnia duration of 3.90 years (± 2.03) received treatment that included one in-person and three telephone sessions of behavioral intervention and incorporated electronic delivery components. Feasibility indicators and preliminary treatment effectiveness were assessed., Findings: Results indicate the preference-based treatment was acceptable to veterans and feasible to implement. Treatment components delivered in-person were used more than electronic methods. Insomnia decreased from moderate severity to the sub-threshold range. Pre- to post-treatment effect sizes were large for most sleep outcomes. Sleep improvement maintained at the 3-month follow-up assessment., Conclusion: Further testing of a brief insomnia treatment model is needed., Clinical Relevance: Successful insomnia treatment has the potential to maximize rehabilitation outcomes in Operations Enduring Freedom and Iraqi Freedom veterans and may provide a non-stigmatizing entry to mental health services., (© 2013 Association of Rehabilitation Nurses.)

Study Objective: Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment., Design: A randomized, controlled study., Setting: Veterans Affairs medical center., Participants: 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia., Interventions: Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group., Measurements and Results: Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters., Conclusions: For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate., Clinical Trial Information: Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1.

Sleep difficulty is a prevalent problem among returning Veterans. Although there is strong evidence for the efficacy and durability of cognitive-behavioral treatment for insomnia (CBT-I) in the general population, the interventions require motivation, attention, and adherence from patients to achieve successful outcomes. Given the unique characteristics of Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans who have experienced blast-related injuries and other trauma, CBT-I for these patients may require modification, including alternative delivery methods, to ensure effective implementation and positive outcomes. We interviewed 18 OIF/OEF Veterans who screened positive for mild traumatic brain injury and 19 healthcare providers to determine the acceptability of insomnia treatments and preferences for the interventions and treatment delivery. Veterans and providers had distinct preferences for insomnia treatment and its delivery. The treatments the Veterans found most acceptable were also the ones they preferred: relaxation treatment and pharmacotherapy. The providers identified relaxation therapy as the most acceptable treatment. Veterans preferred the individual treatment format as well as electronic methods of treatment delivery. Despite some differences between patients and providers, a compromise through modification of empirically supported behavioral treatments is feasible, and implications for preference-based insomnia intervention development and testing are discussed.

Sleep disturbance is intricately entwined with our sense of well-being, health, emotion regulation, performance and productivity, memory and cognitive functioning, and social interaction. A longitudinal perspective underscores the conclusion that persistent sleep disturbance, insomnia, at any time during the life span from infancy to old age has a lasting impact. We examine how insomnia develops, the evidence for competing explanations for understanding insomnia, and the evidence about psychological and behavioral treatments that are used to reduce insomnia and change daytime consequences. There are new directions to expand access to treatment for those who have insomnia, and thus a critical analysis of pathways for dissemination is becoming increasingly important., (© 2011 by Annual Reviews. All rights reserved)

Background: The literature on preferences for behavioral interventions is limited in terms of understanding treatment-related factors that underlie treatment choice. The objectives of this study were to examine the direct relationships between personal beliefs about clinical condition, perception of treatment acceptability, and preferences for behavioral interventions for insomnia., Methods: The data set used in this study was obtained from 431 persons with insomnia who participated in a partially randomized clinical trial and expressed preferences for treatment options. The data were collected at baseline. Logistic regression was used to examine the relationships between personal beliefs and treatment acceptability, and preferences. The relationships between personal beliefs and perception of treatment acceptability were explored with correlational analysis., Results: Perception of treatment acceptability was associated with preferences. Persons viewing the option as convenient tended to choose that option for managing insomnia. Personal beliefs were not related to preferences. However, beliefs about sleep promoting behaviors were correlated with perceived treatment effectiveness., Conclusions: Perception of treatment acceptability underlies expressed preferences for behavioral interventions. Personal beliefs about insomnia are not directly associated with preferences. Importance is highlighted for providing information about treatment options and exploring perception of each option's acceptability during the process of treatment selection.

The purpose of this study was to determine if breast cancer survivors (BCS) with insomnia can be grouped according to their level of fatigue. A secondary data analysis was conducted on baseline data obtained from a randomized clinical trial that focused on a cognitive-behavioral intervention for insomnia in BCS. Participants were BCS (n = 86) with insomnia who were at least 3 months after completion of primary treatment without current evidence of disease. Three subgroups of women were identified with significant differences in fatigue, including exhausted (35%), tired (41%), and restored (24%). Results suggest that most women have moderate to severe fatigue many years after completion of treatment. Severe fatigue was associated with higher levels of other symptoms and poorer quality of life (exhausted subgroup). Significant differences in insomnia severity, anxiety, depression, and quality of life were noted among the exhausted, tired, and restored subgroups. The existence of fatigue-based subgroups offers important information when providing care to BCS. By determining symptoms associated with fatigue, patient care will benefit through a shift in focus from treatment of a single symptom such as fatigue to the delivery of a tailored intervention that targets multiple symptoms.

Systematic measurement of treatment preferences is needed to obtain well-informed preferences. Guided by a conceptualization of treatment preferences, a measure was developed to assess treatment acceptability and preference. The purpose of this study was to evaluate the psychometric properties of the treatment acceptability and preferences (TAP) measure. The TAP measure contains a description of each treatment under evaluation, items to rate its acceptability, and questions about participants' preferred treatment option. The items measuring treatment acceptability were internally consistent (alpha > .80) and demonstrated validity, evidenced by a one-factor structure and differences in the scores between participants with preferences for particular interventions. The TAP measure has the potential for the assessment of acceptability and preferences for various behavioral interventions., (Copyright 2009 Wiley Periodicals, Inc.)

Limited information is known about insomnia, depression, and distress in men with prostate cancer. This study explored insomnia and its relationship to depression and distress in this population. Participants (N = 51) were recruited from a Veterans Affairs Medical Center outpatient clinic. Questionnaires included the Insomnia Severity Index, Center for Epidemiologic Studies-Depression Scale, and Impact of Event Scale. Findings indicated that many men had insomnia and depression with a moderate level of distress. Half the men with clinically significant insomnia also had clinically significant depression. Significant relationships were found among insomnia, depression, and distress. Implications for research and practice are offered.

Background: Few studies have characterized the effects of cancer diagnosis and treatment on sleep quality in men with cancer, and even fewer have identified mediators between psychosocial factors and physical symptoms. It has been debated whether active, approach-oriented, coping behaviors or more passive, avoidance-oriented, coping behaviors are more important to the preservation of sleep quality., Purpose: This study tested the impact of coping style (i.e., approach vs. avoidance) on sleep quality and depressive symptoms and intrusive thoughts as putative mediators., Methods: Utilizing a longitudinal design, men with cancer (N = 55) were assessed at study entry (T1) and again 6 months later (T2). Two indicators of sleep quality were assessed: severity of sleep disturbance symptoms and resulting interference with daily functioning from sleep problems., Results: Higher use of avoidance coping at T1 was related to greater severity in sleep-related symptoms (p < 0.01) and more interference with daily functioning (p < 0.001) at T2. Approach coping at T1 was unrelated to indicators of sleep quality. Depressive symptoms and not intrusive thoughts mediated the relationship between avoidance coping and sleep symptom interference and partially mediated the effect on sleep symptom severity based on examination of bootstrapped standard errors for indirect paths., Conclusions: Avoidance of cancer-related stressors and circumstances likely contributes to declines in mood states and in turn compromises sleep. An individual's coping style may be an important consideration in the assessment and treatment of sleep problems in men with cancer.

Aim: This paper is a report of a study to describe the efficacy of cognitive behavioural therapy for insomnia on fatigue, mood and quality of life in breast cancer survivors., Background: Women who receive primary treatment for breast cancer often complain of insomnia. Rarely evaluated in insomnia intervention studies is the effect of cognitive behavioural treatment on the psychosocial outcomes of fatigue, mood and quality of life., Method: Data were collected between December 2002 and March 2004 with 72 women who were at least 3 months post-completion of primary treatment without current evidence of disease. Women were randomly assigned to either the cognitive behavioural therapy for insomnia group, which received stimulus control instructions, sleep restriction therapy and sleep education and hygiene, or the component control group which received sleep education and hygiene only. The 10-week study consisted of 2 weeks of pre-treatment, 6 weeks of treatment and 2 weeks of post-treatment. Fatigue, mood and quality of life were measured at pre- and post-treatment., Findings: Women receiving cognitive behavioural therapy for insomnia had significant improvements in fatigue, trait anxiety, depression and quality of life. The component control group also had statistically significant increases in quality of life, with a trend suggestive of lower depression at post-treatment., Conclusion: Globally, as the number of survivors in this population continues to grow, it is imperative that nurses continue testing interventions that may positively affect quality of life and the commonly experienced symptoms of fatigue, anxiety and depression.

Purpose/objectives: To determine the efficacy of a cognitive-behavioral intervention for treating insomnia in breast cancer survivors., Design: Randomized controlled trial., Setting: University and medical center settings., Sample: 72 women at least three months after primary treatment for breast cancer with sleep-onset or sleep maintenance insomnia at least three nights per week for at least three months as determined through daily sleep diaries., Methods: Random assignment to a multicomponent intervention (stimulus control instructions, sleep restriction, and sleep education and hygiene) or a single-component control group (sleep education and hygiene)., Main Research Variables: Sleep-onset latency, wake after sleep onset, total sleep time, time in bed, sleep efficiency, and sleep quality., Findings: After the intervention, both groups improved on sleep-onset latency, wake after sleep onset, total sleep time, time in bed, sleep efficiency, and sleep quality based on daily sleep diaries. A between-group difference existed for time in bed. Wrist actigraph data showed significant pre- to postintervention changes for sleep-onset latency, wake after sleep onset, total sleep time, and time in bed. When compared to the control group, the multicomponent intervention group rated overall sleep as more improved., Conclusions: A nonpharmacologic intervention is effective in the treatment of insomnia in breast cancer survivors., Implications for Nursing: Breast cancer survivors can benefit from a cognitive-behavioral intervention for chronic insomnia. Sleep education and hygiene, a less complex treatment than a multicomponent intervention, also is effective in treating insomnia.

The incongruence length difference (ILD) test is prone to suggesting significant conflict between character partitions when these differ only in the amount of undirected homoplasy (noise). This has been shown to be due to nonlinearity in the relationship between tree length and noise. Here we show that by standardizing either tree length or 1-retention index on a 0-to-1 scale, and then taking the arcsine of the value, the resulting value is linearly related to noise except at extremely high noise levels. We then investigate the effect of substituting these values instead of raw tree metrics in a modified ILD test (here called arcsine-ILD) for two types of noise. We show that, using the modified metric instead of the raw length, the results of ILD tests agreed better with desirable properties.

Evaluating the effectiveness of nursing care is necessary for developing a sound knowledge base to guide practice. Several studies have been conducted to evaluate the effectiveness of nursing care or interventions in producing the desired outcomes. While the results of these studies are encouraging, they do not provide a comprehensive and realistic evaluation of the contribution of nursing. Factors related to patient characteristics and implementation of care are not accounted for. The outcomes selected do not reflect the direct benefits of nursing care or interventions. In this paper, research methods for conducting effectiveness research in a way that would identify the unique contribution of nursing care delivered under the conditions of the real world of everyday practice are discussed. Examples are provided to illustrate the points of discussion.

Effectiveness research is undertaken to evaluate the effects of interventions in achieving desired outcomes when tested in the real-world conditions of everyday practice. Although the randomized clinical trial (RCT) is considered the gold standard for effectiveness research, its feasibility, generalizability, and the clinical utility of its results are being questioned. This state of the science prompted the call for a paradigm shift, characterized by alternative methods for clinical research. The alternative methods attempt to account for clinical realities when conducting research, with the goal of minimizing discrepancies in the perspective and assumptions underlying practice and research. In this article a theory-driven approach to intervention evaluation is presented as a viable alternative paradigm for clinical research. The application of this approach demands changes in four aspects of research: participant selection criteria, assignment to treatment options, delivery of the intervention, and selection of outcome measures. The changes are discussed at the conceptual level and illustrated with examples from an ongoing multisite study aimed at determining the usefulness of this theory-driven approach to intervention evaluation., (Copyright 2003 Wiley Periodicals, Inc. Res Nurs Health 26: 244-255, 2003)

Patients with persistent insomnia are long-suffering and in dire need of treatment. These individuals can be a challenge to treat. Duration and severity of the problem, current and prior use of sleeping medications, medical and psychiatric conditions, and experience with rebound insomnia are just some of the factors that affect treatment. Most of the insomnia problems that nurses encounter are secondary to a medical or psychiatric condition. Knowledge of assessment methods and implementation of nonpharmacological interventions can make a substantial contribution to the quality of life of persons with insomnia.

Turkeys were surgically prepared with two strain gauge transducers on each cecum to detect both major and minor contractions at each implant site and to allow appraisal of coordination of contractions within and between ceca at the time of cecal evacuation and at dawn. There were significantly more of both types of contractions and significantly more major than minor contractions immediately before than after evacuation. At dawn the frequency of minor contractions was significantly greater than that of major contractions and there were significantly more contractions immediately after dawn than before dawn. Contractile activity was more often not coordinated than coordinated at anytime both within and between the ceca. When there was coordination within each cecum before evacuation, it was more frequently orad oriented than aborad. Near dawn the occurrence of coordinated contractions within each cecum was not significantly different from the occurrence of no coordination and the latter occurred significantly more frequently than did coordination between the two ceca.